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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Christine Johnson, Stanford University Identifier:
First received: January 19, 2012
Last updated: May 20, 2015
Last verified: May 2015

A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes and death for premature infants. Infants with BPD are also at high risk for pulmonary hypertension (PH)—an important contributor to their condition. Previous research has suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary disease.

This study aims to investigate the incidence of incidence of PH and levels of ET-1 among premature babies with BPD. It will also potentially allow us to focus further research efforts and treatment towards these infants, some of our sickest patients at LPCH.This study aims to 1) investigate the incidence of PH among premature infants with BPD versus those without BPD; 2) investigate ET-1 levels in infants with BPD-associated PH versus those without BPD-associated PH; and 3) investigate BNP (brain natriuretic peptide) values in infants with BPD-associated PH versus those without BPD-associated PH. This study will allow us to help define a high-risk population at LPCH—namely, premature infants with BPD-associated PH.

Bronchopulmonary Dysplasia (BPD)
Pulmonary Hypertension (PH)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endothelin-1 (ET-1) and Brain Natriuretic Peptide (BNP) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Infant develops BPD [ Time Frame: 36 weeks of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant develops PH [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 30 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
LPCH premature neonates

Inclusion Criteria:

  • Premature Infants (<30 weeks EGA)

Exclusion Criteria:

  • Major congenital malformations (cardiac, respiratory, gastrointestinal)
  • congenital infection, and/or
  • known genetic syndromes (i.e. trisomy 21)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01516398

United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Principal Investigator: Christine Johnson, MD Stanford University
  More Information

Responsible Party: Christine Johnson, Principle Investigator, Stanford University Identifier: NCT01516398     History of Changes
Other Study ID Numbers: BPD22044 
Study First Received: January 19, 2012
Last Updated: May 20, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension, Pulmonary
Bronchopulmonary Dysplasia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases processed this record on September 26, 2016